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目的评价痰热清注射液及痰热清注射液联合中药汤剂治疗手足口病并发中枢神经系统感染的安全性和临床疗效。方法采用前瞻性、多中心、随机、对照的临床研究方法,在6个中心共纳入329例手足口病并发中枢神经系统感染的住院患儿,采用整体随机化方法,将其按照随机编码表随机分入西医综合治疗组(以下简称A组)、西医综合治疗加用痰热清注射液治疗组(以下简称B组)、西医综合治疗加用痰热清注射液及中药汤剂口服或灌肠治疗组(以下简称C组)。以病情稳定时间、体温稳定时间、危重型转化率为主要指标,动态评估病情变化,评价不同干预措施的临床疗效。结果共纳入有效病例327例,病原学检测结果以肠道病毒71型(EV71)感染为主(74.4%),三组在病原感染型别、性别、年龄、入组病程、病程中最高体温等基线资料方面分布均衡,但基线体温提示B组体温偏高,C组次之,而A组体温最低(P=0.044)。A组、B组、C组三组的病情稳定时间分别为(62.1±42.3)h、(58.7±35.6)h、(57.6±35.2)h,B组、C组的病情稳定时间有缩短的趋势;体温稳定的时间分别为(36.5±23.5)h、(41.2±27.0)h、(39.7±28.8)h,差异无统计学意义(P>0.05);危重型转化率分别为A组4.6%、B组6.4%、C组3.7%,差异无统计学意义(P>0.05)。以病原学为依据进行亚组分析,发现除EV71、柯萨奇病毒A16型(CoxA16)以外的其他肠道病毒感染患者中,A、B、C三组的体温稳定时间分别为(56.0±35.3)h、(26.3±19.6)h、(45.5±14.2)h,B组明显短于A组,差异有统计学意义(P<0.05)。结论中医药治疗有缩短手足口病并发中枢神经系统感染病情稳定时间的趋势,对于手足口病并发中枢神经系统感染具有一定的潜在价值。
Objective To evaluate the safety and clinical efficacy of Tanreqing Injection and Tanreqing Injection combined with traditional Chinese medicine decoction for treating hand-foot-mouth disease complicated by central nervous system infection. Methods A prospective, multicenter, randomized, controlled clinical study was conducted in 329 children with HFMD inpatients with central nervous system infection in 6 centers. The patients were randomized according to the random code table Into the Western comprehensive treatment group (hereinafter referred to as A group), Western medicine combined with Tanreqing injection treatment group (hereinafter referred to as B group), Western medicine combined with Tanreqing injection and traditional Chinese medicine decoction oral or enema treatment Group (hereinafter referred to as C group). Stable condition time, temperature stabilization time, critical conversion rate as the main indicators, dynamic assessment of disease changes, evaluate the clinical efficacy of different interventions. Results A total of 327 valid cases were enrolled in the study. The results of pathogenic tests were mainly based on EV71 infection (74.4%). The infection rate, gender, age, duration of disease, maximum body temperature Baseline data were evenly distributed, but baseline body temperature suggested higher body temperature in group B followed by group C, while body temperature in group A was the lowest (P = 0.044). The stable time of group A, group B and group C were (62.1 ± 42.3) h, (58.7 ± 35.6) and (57.6 ± 35.2) h, respectively. The stable time of group B and C were shortened (36.5 ± 23.5) h, (41.2 ± 27.0) h and (39.7 ± 28.8) h, respectively, with no significant difference (P> 0.05). The critical conversion rate was 4.6% in group A, 6.4% in group B and 3.7% in group C, with no significant difference (P> 0.05). A subgroup analysis based on the etiology found that in patients with enterovirus infection other than EV71 and CoxA16, the body temperature stabilization time in groups A, B and C were (56.0 ± 35.3 ) h, (26.3 ± 19.6) h and (45.5 ± 14.2) h, respectively. The difference between the two groups was statistically significant (P <0.05). Conclusion TCM has the tendency of shortening the stable time of HFMD complicated by central nervous system infection and has some potential value for HFMD complicated by CNS infection.